Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01818583 |
Recruitment Status
:
Recruiting
First Posted
: March 26, 2013
Last Update Posted
: December 28, 2016
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | March 22, 2013 | ||||||||
First Posted Date ICMJE | March 26, 2013 | ||||||||
Last Update Posted Date | December 28, 2016 | ||||||||
Study Start Date ICMJE | March 2013 | ||||||||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Cardioversion (time and percentage) [ Time Frame: 24 hours ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01818583 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At about 3 months follow up, plus additional 3 days ECG-monitoring ] The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
|
||||||||
Original Secondary Outcome Measures ICMJE |
Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At 3 months follow up, plus additional 3 days ECG-monitoring ] The patients will be followed up with a resting ECG three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
|
||||||||
Current Other Outcome Measures ICMJE |
Adverse events [ Time Frame: During time of infusion ] | ||||||||
Original Other Outcome Measures ICMJE | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter | ||||||||
Official Title ICMJE | Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter | ||||||||
Brief Summary | Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the general population. The prevalence of atrial fibrillation increases with age. Between 50 and 70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm. Another treatment option for conversion of atrial fibrillation and atrial flutter is electrical conversion. This is an effective treatment but requires anesthesia. Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such converting drugs all have potentially serious side effects and are expensive. Potassium, sodium, calcium, and magnesium molecules are the most important ions causing electric current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side effects. |
||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arms |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
150 | ||||||||
Original Estimated Enrollment ICMJE |
218 | ||||||||
Estimated Study Completion Date | March 2018 | ||||||||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender |
|
||||||||
Ages | 18 Years and older (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | Norway | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01818583 | ||||||||
Other Study ID Numbers ICMJE | AK-01 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement |
|
||||||||
Responsible Party | Kiarash Tazmini, Diakonhjemmet Hospital | ||||||||
Study Sponsor ICMJE | Diakonhjemmet Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Diakonhjemmet Hospital | ||||||||
Verification Date | December 2016 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |